A Study to Evaluate Safety and Efficacy of PHX1149T in Subjects With Type 2 Diabetes Mellitus

Phenomix

Status and phase

Unknown

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: PHX1149T

Study type

Interventional

Funder types

Industry

Identifiers

NCT00482950

PHX1149-Prot202

Details and patient eligibility

About

This study is to test the efficacy and safety of PHX1149T in combination with metformin, a glitazone, or metformin and a glitazone in subjects with Type 2 diabetes for 12 weeks. After completing the 12 week double blind part of the study, subjects can enter an open label extension study

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Entry Criteria:

Type 2 diabetes mellitus, diagnosed at least 4 months but not more than 12 years prior to screening.
Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 25 to 48 kg/m2, inclusive. For India the BMI is 23 to 48 kg/m2, inclusive.
Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of 1500 mg or more (or the highest tolerated dose), or TZD (any labeled dose), or metformin + TZD at doses used in accordance with product labeling for at least 4 weeks (metformin) or 10 weeks (TZD) prior to screening (Visit 1).
Fasting plasma glucose of 118 - 220 mg/dL (6.6 - 12.2 mmol/L), inclusive; HbA1c 7.3% - 11.0%, inclusive; and a fasting plasma C peptide greater than 0.26 nmol/L at screening. For Argentina the allowed upper limit of HbA1c is ≤ 10.5%. For Canada the upper limit will be 10.0%
No Type 1 diabetes mellitus or marked diabetic long-term complications.